Pharmaceutical Technology Editors

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

Ethics Group Calls on FTC to Investigate Drug Pricing

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

A roundup of developments on corporate social responsibility from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

The US Food and Drug Administration's website now features a free online 90-minute training program on the "Past, Present, and Future of FDA Human Drug Regulation."

Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.

The European Medicines Agency and the European Monitoring Center for Drugs and Drug Addiction to Cooperate.

GSK Acquires Laboratorios Phoenix; Catalent Makes Executive Appointments; And More.

A roundup of developments on corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other organizations.

Thermo Fisher to Acquire Fermentas; Pfizer Names Head of R&D; And More.

Regulatory Roundup: USP and Russia's Roszdravnadzor Sign MOU

The US Food and Drug Administration began a partnership with the website Drugs.com to expand access to the agency's consumer-health information.

Despite its potential, why is personalised medicine still not widely used in healthcare?

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

FDA and NIH Launch New Safety Reporting Website; And More.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

FDA Clears Infant Rotavirus Vaccine

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

Sundlof Resigns as FDA's Head of Food Safety; and More

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

The author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."